Drug Facts 76378-011

SPL v5

SPL

SPL Set ID a4535b70-04cb-4227-81d3-4dd55086ba7a

Route

TOPICAL

Published

Effective Date 2011-08-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Diethanolamine Bis(c8-c18 Perfluoroalkylethyl)phosphate Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-02-01

Description

Active Ingredient Ethyl Alcohol 62% v/v

Medication Information

Warnings and Precautions

Warnings

Flammable, keep away from fire and flames

For external use only

Indications and Usage

Use

for hand-washing to decrease bacteria on the skin

If hands are visibly soiled, use regular soap and water

Recommended for repeated use

Dosage and Administration

Directions

apply to hands and rub lightly until dry without wiping or rinsing

Description

Active Ingredient Ethyl Alcohol 62% v/v

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if

irritation and redness develop

Section 50567-7

When using this product

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Section 51727-6

Inactive Ingredients

water, DEA-C8-18 perfluoro-alkylethyl phosphate, propylene glycol

Section 51945-4

Servo

Stat-Foam

Waterless

Antiseptic

Item #: 11125R-FM4

1000ML 33.8 FL. OZ.

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 62% v/v

Structured Label Content

Indications and Usage (34067-9)

Use

for hand-washing to decrease bacteria on the skin

If hands are visibly soiled, use regular soap and water

Recommended for repeated use

Dosage and Administration (34068-7)

Directions

apply to hands and rub lightly until dry without wiping or rinsing

Warnings and Precautions (34071-1)

Warnings

Flammable, keep away from fire and flames

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

irritation and redness develop

Section 50567-7 (50567-7)

When using this product

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Section 51727-6 (51727-6)

Inactive Ingredients

water, DEA-C8-18 perfluoro-alkylethyl phosphate, propylene glycol

Section 51945-4 (51945-4)

Servo

Stat-Foam

Waterless

Antiseptic

Item #: 11125R-FM4

1000ML 33.8 FL. OZ.

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62% v/v

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE", "unii": "4J55VM509S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use for hand-washing to decrease bacteria on the skin If hands are visibly soiled, use regular soap and water Recommended for repeated use", "34068-7": "Directions apply to hands and rub lightly until dry without wiping or rinsing", "34071-1": "Warnings Flammable, keep away from fire and flames For external use only", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if irritation and redness develop", "50567-7": "When using this product do not get into eyes if contact occurs, rinse eyes thoroughly with water", "51727-6": "Inactive Ingredients water, DEA-C8-18 perfluoro-alkylethyl phosphate, propylene glycol", "51945-4": "Servo Stat-Foam Waterless Antiseptic Item #: 11125R-FM4 1000ML 33.8 FL. OZ.", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredient Ethyl Alcohol 62% v/v"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.091980 · Updated: 2026-03-14T23:05:22.628914